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CMS and FDA launch RAPID pathway for breakthrough device coverage

CMS and FDA launch RAPID pathway for breakthrough device coverage

Rule Changes
By Newzino Staff |

Medicare coverage for FDA-approved breakthrough devices could arrive as fast as two months after authorization, down from roughly a year

Today: RAPID coverage pathway announced

Overview

For nearly a decade, medical device makers have faced the same bottleneck: the FDA clears a breakthrough device, and then Medicare spends another year or more deciding whether to pay for it. On April 23, the two agencies announced a joint pathway to collapse that gap to as little as two months.

Why it matters

Medicare beneficiaries with serious heart, neurological, and chronic conditions could access newly approved devices nearly a year earlier than before.

Key Indicators

~2 months
New time to Medicare coverage
Target interval between FDA market authorization and final national coverage decision under RAPID.
1 year+
Current time to coverage
Typical delay between FDA clearance and a Medicare national coverage decision under existing process.
~40
Devices eligible now
Breakthrough devices that could qualify for the RAPID pathway immediately, per a senior CMS official.
~20
Additional potential qualifiers
Further devices that could meet RAPID criteria as evidence plans develop.
60 days
Public comment period
Federal Register comment window on the proposed procedural notice before CMS finalizes the pathway.
~250
Cardiology breakthrough devices
Cardiology has the largest share of devices in the FDA Breakthrough Devices Program and stands to benefit most.

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People Involved

Marty Makary
Marty Makary
Co-announcing RAPID pathway
 Dr. Mehmet Oz
Dr. Mehmet Oz
Co-announcing RAPID pathway

Organizations Involved

Centers for Medicare & Medicaid Services
Centers for Medicare & Medicaid Services
Federal Agency
Issuing proposed procedural notice

The federal agency that decides what Medicare pays for and at what rate.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal Agency
Co-issuing RAPID pathway

The federal agency that reviews medical devices for safety and effectiveness before market authorization.
AdvaMed
AdvaMed
Industry Trade Association
Supporting pathway, lobbying for broader coverage

The largest U.S. trade association representing medical device manufacturers.

Timeline

  1. RAPID coverage pathway announced

    Regulation

    CMS and FDA jointly announce the Regulatory Alignment for Predictable and Immediate Device pathway, targeting Medicare coverage as fast as two months after FDA clearance.

  2. CMS proposes payment rollback for breakthrough devices

    Regulation

    CMS proposes eliminating the alternate new technology add-on payment pathway that lets breakthrough devices skip the substantial-clinical-improvement test.

  3. TCET pathway finalized

    Regulation

    CMS finalizes TCET, targeting a six-month national coverage decision after FDA authorization, capped at roughly five devices per year.

  4. TCET pathway proposed

    Regulation

    CMS publishes proposed Transitional Coverage for Emerging Technologies pathway, a narrower successor to MCIT.

  5. Biden CMS rescinds MCIT

    Regulation

    CMS repeals the MCIT rule, citing insufficient patient safeguards and weak incentives for post-market evidence development.

  6. MCIT rule finalized

    Regulation

    Outgoing Trump administration finalizes Medicare Coverage of Innovative Technology rule granting four years of automatic Medicare coverage to FDA breakthrough devices.

  7. 21st Century Cures Act signed into law

    Legislation

    Creates the FDA Breakthrough Devices designation, giving priority review to devices that treat serious conditions with unmet medical need.

Scenarios

1

RAPID finalized as proposed, first devices covered by late 2026

Discussed by: AdvaMed, STAT, MedTech Dive analysts

The 60-day comment period closes with support from industry and muted pushback from payer-evidence groups. CMS finalizes the procedural notice in the third quarter, and the first two to three breakthrough devices — likely cardiology implants — secure national coverage within two months of FDA clearance by year-end. Manufacturers move trial designs to pre-align evidence with CMS.

2

Faster coverage, smaller payments: RAPID paired with add-on rollback squeezes economics

Discussed by: Modern Healthcare, Healthcare Dive, device-industry analysts

RAPID advances alongside CMS's April 15 proposal to strip breakthrough devices of preferential new technology add-on payments. Devices gain coverage faster but at standard reimbursement rates, narrowing the commercial upside manufacturers expected. Smaller firms with thin margins delay launches or deprioritize Medicare populations in trial design.

3

Comment period surfaces evidence concerns, CMS adds safeguards

Discussed by: Health Affairs authors, former CMS coverage officials

Patient advocacy and health services researchers echo the 2021 critique that triggered MCIT's repeal: real-world performance in Medicare populations often diverges from pivotal trial data. CMS responds in its final notice by requiring mandatory coverage with evidence development or shorter coverage durations, trimming the two-month timeline in practice.

4

Legal challenge to same-day proposed NCD

Discussed by: Health law practitioners, Reed Smith health regulatory blog

Critics argue that issuing a proposed national coverage determination on the day of FDA clearance bypasses the deliberative review Medicare statute contemplates. A payer coalition or beneficiary group files suit seeking to block the pathway, forcing CMS to defend its statutory authority and potentially delaying first coverage decisions.

Historical Context

MCIT rule and rescission (2021)

January–November 2021

What Happened

In its final days, the first Trump administration finalized the Medicare Coverage of Innovative Technology rule, giving FDA breakthrough devices four years of automatic Medicare coverage starting at market authorization. The Biden CMS delayed implementation, then formally repealed the rule in November 2021, arguing the four-year window cut off the agency's ability to demand evidence on how devices performed in older, sicker Medicare patients.

Outcome

Short Term

Device makers lost automatic coverage; the coverage gap reverted to roughly a year or longer. AdvaMed launched a multi-year lobbying push for a replacement.

Long Term

The rescission established that tying Medicare coverage directly to FDA approval raised unresolved evidence-standard questions, forcing successor programs to build in pre-market evidence negotiation rather than post-market automatic coverage.

Why It's Relevant Today

RAPID is the third attempt to bridge the FDA-to-Medicare gap. It borrows MCIT's speed ambition but answers the 2021 critique by requiring Medicare-specific trial enrollment and agreed outcomes before approval — not coverage first, evidence later.

TCET pathway finalized (2024)

August 2024

What Happened

The Biden CMS finalized the Transitional Coverage for Emerging Technologies pathway, targeting a six-month national coverage decision after FDA breakthrough device authorization. The program accepted up to five devices per year, required coverage with evidence development, and was intended as a modest, defensible successor to MCIT.

Outcome

Short Term

Industry groups welcomed TCET as better than nothing but criticized the five-device cap as far too narrow given the pipeline.

Long Term

TCET set the procedural template — concurrent review, upfront evidence planning — that RAPID scales up. RAPID removes the five-device cap, cuts the timeline further, and broadens eligibility to include Class II devices in FDA's TAP program.

Why It's Relevant Today

RAPID is essentially TCET with the throttle removed. Whether the faster timeline survives public comment intact will hinge on whether the evidence safeguards carried over from TCET persuade skeptics.

FDA Breakthrough Therapy designation for drugs (2012)

July 2012

What Happened

Congress created the Breakthrough Therapy designation under FDASIA, letting FDA work closely with drug sponsors from early development to speed approval of therapies for serious conditions. Unlike devices, drugs face a separate Medicare coverage mechanism (Part B/D) that does not require national coverage determinations for most products, so approval and reimbursement historically ran in closer sequence.

Outcome

Short Term

Dozens of cancer, rare disease, and infectious disease drugs reached patients one to two years earlier than traditional review would have allowed.

Long Term

The designation normalized the idea that regulators can engineer closer collaboration with sponsors on evidence design without abandoning safety and efficacy standards — the template RAPID now extends to devices plus payers.

Why It's Relevant Today

Drugs have had an accelerated front door for more than a decade; devices never bridged the coverage gap that separates approval from reimbursement. RAPID is the structural import of that drug-side playbook into the device and Medicare coverage world.

Sources

(10)
+4
FDA STAT Healthcare Dive MedTech Dive Fierce Healthcare AdvaMed CMS Cardiovascular Business CMS STAT